Press Release

October 22, 2021
1 min read

Phase 3 trial of regimen for metastatic colorectal cancer misses primary endpoint


Press Release

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A phase 3 trial designed to assess trifluridine and tipiracil plus bevacizumab as first-line treatment for certain patients with advanced colorectal cancer missed its primary endpoint.

Trifluridine and tipiracil (Lonsurf, Taiho Oncology) is an oral agent that utilizes a dual mechanism of action to maintain clinical activity. Trifluridine, an antineoplastic nucleoside analogue, interferes with DNA function. The blood concentration of trifluridine is maintained via tipiracil, an inhibitor of the trifluridine-degrading enzyme thymidine phosphorylase.

Human colon cancer cells with the cell nuclei stained red and the protein E-cadherin stained green.
Source: NCI Center for Cancer Research.

The randomized phase 3 SOLSTICE trial includes 856 patients with unresectable metastatic colorectal cancer who are not candidates for or do not require intensive therapy.

Researchers randomly assigned half of the patients to first-line trifluridine and tipiracil plus bevacizumab (Avastin, Genentech). The other half received capecitabine plus bevacizumab.

The trial failed to meet its primary objective of a significant PFS benefit with trifluridine and tipiracil plus bevacizumab.

Complete data from this analysis will be submitted for presentation at a medical meeting.

No new safety issues or deleterious effects have been observed in either treatment group, so the trial will continue as planned.

“We remain committed to improving outcomes in metastatic colorectal cancer and we will continue to follow patients as planned in order to perform the main secondary endpoint analysis on overall survival in 2023,” Patrick Therasse, MD, PhD, head of late-stage and life cycle management and deputy head of the oncology and immuno-oncology therapeutic area for Servier — which is co-developing trifluridine and tipiracil with Taiho Pharmaceutical Co. in Europe and other countries outside the United States — said in a company-issued press release. “The clinical value of Lonsurf in its current indications remains unchanged.”

The ongoing phase 3 SUNLIGHT trial — designed to compare trifluridine/tipiracil plus bevacizumab vs. trifluridine/tipiracil alone as third-line treatment for metastatic colorectal cancer — will proceed as planned, Therasse said.